Brand Name Choices
No generic medication is available for Videx EC (Didanosine)
What Videx EC is and what it is used for
Videx is an antiviral (or antiretroviral) medicine, used to treat Human Immunodeficiency Virus (HIV) infection. Videx belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs). It is normally used in combination with other anti-HIV medicines. Videx is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people
How to take Videx EC
• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The capsules must be swallowed whole with a full glass of water.
• Do not open or break Videx capsules.
• Take Videx capsules on an empty stomach at least 2 hours before or 2 hours after a meal. Videx is not absorbed well if there is food in the stomach. How much to take Not all patients need to take the same dose of Videx. The usual dose for adults is based on your body weight, as follows: Your body weight Total Daily Dose Less than 60 kg 250 mg, either once daily, or in two 125 mg doses (taken approximately 12 hours apart). 60 kg or more 400 mg, either once daily, or in two 200 mg doses (taken approximately 12 hours apart). 4 Depending on the side effects you may develop and the diseases you are suffering from at the beginning of your treatment (e.g. pancreatitis, renal impairment), your doctor may prescribe a different dose. Use in children The dose for children older than 6 years will be based on body surface area which the doctor will calculate. The usual dose is between 120 and 360 mg a day, taken as a single dose, once daily. Videx capsules must not be taken by children under 6 years. Other more appropriate formulations are available for children in this age group. If you take more Videx than you should If you have taken more Videx than was prescribed by your doctor, or if someone accidentally takes Videx, contact your doctor or the nearest hospital immediately. If you forget to take Videx It is important that you do not miss any doses. If you miss a dose of Videx, take it as soon as possible, but on an empty stomach at least 2 hours before or after a meal, and then take your next scheduled dose at its regular time. However, if it is almost time for your next dose, do not take the missed dose, but wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten dose. If you stop taking Videx Do not stop taking Videx before talking with your doctor. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The virus may then become harder to treat. If you have any further questions on the use of this medicine, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you feel stomach pain or abdominal pain. This may be due to
inflammation of the pancreas which can become life-threatening if left untreated (see Warnings and
Tell your doctor if you notice any of the following side effects:
Very common side effects(These are likely to affect more than 1 in every 10 patients)
• Digestive problems: diarrhoea
Common side effects (These are likely to affect between 1 to 10 in every 100 patients)
• Liver problems: hepatitis (inflammation of the liver)
• Nervous system: peripheral neurologic symptoms (numbness, weakness, tingling or pain in the arms and the legs), headache
• Digestive problems: nausea, vomiting, abdominal pain, flatulence (wind), dry mouth
• Skin: rash
• General: unusual tiredness or weakness, chills and fever, pain
• Reproductive system and breast disorders: breast enlargement in males
• Metabolism and nutrition: anorexia
• Muscles and bones: muscle pain, joint pain
• Tests may show: increased levels of uric acid, increased bilirubin, increased or abnormal levels of some enzymes including liver enzymes in the blood 5
Uncommon side effects (These are likely to affect between 1 to 10 in every 1,000 patients)
• Digestive problems: pancreatitis
• Liver problems: excess of fat in the liver, liver failure
• Metabolism and nutrition: lactic acidosis (excess of lactic acid in the blood), diabetes (starting or getting worse), low or high blood sugar levels
• Blood: low red blood cell count, low blood platelet count, lack of white blood cells
• Muscles and bones: muscle tenderness or weakness, temporary paralysis or weakness of muscles including kidney disease and haemodialysis
• Eyes: dry eyes, changes in colour of the retina, disease of the nerves of the eyes causing blindness
• Infections: sore saliva glands
• Immune system: sudden life threatening allergic reaction
• Skin: alopecia (unusual hair loss or thinning)
Rare side effects(These are likely to affect between 1 to 10 in every 10,000 patients)
• Liver problems: portal hypertension (high blood pressure in the large vein of the liver)
• Muscles and bones: disease of the muscles
• Digestive problems: parotid gland enlargement Treatment with didanosine (Videx) often causes a loss of fat from legs, arms and face (lipoatrophy). This loss of body fat has been shown to be not fully reversible after discontinuation of didanosine. Your doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms and face. When these signs occur, Videx should be stopped and your HIV treatment changed. During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. Side effects in paediatric patients are similar to those seen in adults. Higher blood cells count abnormalities have been reported with the combination with zidovudine. Retinal or optic nerve changes have been reported in a small number of paediatric patients, usually at doses above those currently recommended. Your doctor may decide to carry out a retinal (eye) examination.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie Email: [email protected] United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
How to Store Videx EC
Keep this medicine out of the sight and reach of children. 6 Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month. Do not store Videx capsules above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
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